Cleared Traditional

K904928 - PALAVIT GLC

K904928 is an FDA 510(k) clearance for PALAVIT GLC, manufactured by Kulzer, Inc.. The device is a Class 1 Dental device with product code EGD cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K904928 · Kulzer, Inc. · Dental device
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Jun 1991
Decision
218d
Days
Class 1
Risk

K904928 is an FDA 510(k) clearance for the PALAVIT GLC. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 218 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kulzer, Inc. devices

FDA 510(k) Submission Details - K904928

510(k) Number K904928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1990
Decision Date June 06, 1991
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

EGD Device Classification - Class 1, General Controls

Product Code EGD Wax, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.